ISLAMABAD - The authorities have allowed Shifa International Hospital and Islamabad Diagnostic Centre (IDC) Islamabad to resume administration of Sputnik V vaccine at the health facilities with a direction to take necessary measures to ensure documentation of the storage conditions as per internationally-accepted best practices.
The Drug Regulatory Authority Pakistan (DRAP), Ministry of National Health Services, Regulations and Coordination had asked M/s Shifa International Hospital, sector H-8/4, Islamabad and M/s Islamabad Diagnostic Centre (IDC), G-8 Markaz, Islamabad to immediately stop administering Covid-19 vaccine supplied by M/s AGP Pakistan at the premises for lack of cold chain maintenance. The DRAP teams had inspected both the facilities for verification of cold chain monitoring and storage conditions of the biological product and reported critical observations regarding deviation from the recommended storage temperature (-18c and below) which is mandatory to ensure safety and efficacy of the said biological product besides absence of documentary evidence regarding authorised distributor/vaccine centres.
The permission for resuming administration of the vaccine was given on the basis of ‘documentary evidence of cold chain management provided by the vaccination centre’ and verified from the authorised distribution point of M/s AGP Limited Pakistan for this region, said a letter written by the DRAP to the facilities in continuation of the earlier directions to stop vaccination. The organisations have also been advised to make necessary arrangements like installation of alarm systems and training of employees for handling of temperature-sensitive products.
According to a press release issued by the Shifa International Hospitals Ltd, it is determined to facilitate and outreach to a number of people for provision of Covid-19 vaccination services. “As a national cause, Shifa has established a COVID-19 Vaccination Centre (at H-8/4 Islamabad) which has been duly approved by concerned regulatory authorities: DRAP & Islamabad Healthcare Regulator Authority), said a press release issued by Shifa on Saturday.
It further said that Shifa Vaccination Centre received its first supply of vaccine Sputnik and DRAP team soon after that inspected their vaccination centre premises, vaccine stock, patients record, cold chain maintenance, equipment and power backup system etc. It said that the facility is maintaining medicines and vaccines’ storage as per internationally-accepted best practices and will continue providing Covid-19 vaccination to the general public in compliance with defined safety, storage and handling guidelines.